What is the GastroPanel Blood test?

State of the art diagnostic test for dyspepsia and H. pylori

GastroPanel is a cost effective and evidence based blood test for the Primary Diagnosis of dyspepsia.

Developed by BIOHIT HealthCare, this Finnish innovation meets a universal clinical need by delivering a transformative approach to the investigation of stomach symptoms in Primary Care.

 

With GastroPanel, GPs and clinicians can understand the physiological, biochemical and pathological status of the stomach and by aligning the test with digestive symptoms they are able to rule out diseases, identify acid-disorders, and prioritise referrals for endoscopy.

Why use GastroPanel?

The group of symptoms termed Dyspepsia (i.e. symptoms suggestive of possible diseases of the upper GI tract) places a huge burden on healthcare resources due to the prevalence and poorly-defined nature of the disease. 20-40% of the population suffer from dyspepsia taking up 4% of all GP consultations. Most dyspepsia cases are handled exclusively in a Primary Care  setting, supported by clinical investigations, empirical prescribing of proton pump inhibitors (PPIs) and Helicobacter pylori tests. Occasionally, there is a need to refer patients to secondary care when they present with alarm symptoms or their case suggests the need for specialist investigation.

GastroPanel helps in the early stages of the decision making process by:

  1. Helping direct treatment decisions and patient management,

  2. supporting clinicians when they suspect the need to refer patients, and

  3. providing reassurance when the risk of disease is low.

 

The highly accurate blood test identifies patients at risk of Gastric Cancer, Peptic ulcer disease and Gastritis by identifying precursors to the diseases. It also reports on the capacity for the stomach to produce and secrete gastric acid, helping identify benign acid related disorders that can treated effectively as part of a routine care pathway.

Diagnose Dyspepsia
Validate Treatment Options
Direct Referrals

Helicobacter pylori - a group I carcinogen

Following the discovery of Helicobacter pylori (Hp) in 1984 by Barry Marshall, Robin Warren and their esteemed collaborators, it is now recognised that Hp infection is an unequivocal precursor of gastric cancer (GC) and peptic ulcer disease through a defined cascade of pathogenesis .

 

The current consensus amongst experts suggests that chronic Hp infection causes precursor lesions in the gastric mucosa that progress from superficial (non-atrophic) gastritis, through severe atrophic gastritis (AG) and intestinal metaplasia (IM) to neoplasia and gastric carcinoma. This progression from Hp infection to "intestinal-type" of gastric cancer was defined by Pelayo Correa as early as 1988.

GastroPanel can be considered the most comprehensive test for Helicobacter pylori infection and its clinical sequelae.

GastroPanel technology - how it works

The GastroPanel blood test is based on the detection and quantification of Helicobacter pylori IgG antibodies plus three concurrent stomach-specific biomarkers from a single plasma sample. The test panel utilises standard ELISA principles enabling widespread adoption of the technology and automation for ease of use.
 
The results of the four individual tests undergo algorithmic data reduction using GastroSoft proprietary software to produce a patient-specific report which includes test results, interpretation, and advice on what to do next.
The four parameters that are measured in the GastroPanel blood test are:
  • Helicobacter pylori IgG antibodies (Hp IgG)
  • Pepsinogen I (PGI)
  • Pepsinogen II (PGII)
  • Gastrin 17 (G17)
GastroPanel plasma bimarkers PGI, PGII, G17 and Hp IgG

GastroPanel Plasma Biomarkers

 
GastroPanel measures four parameters from a patient's blood sample: Helicobacter pylori IgG, Pepsinogen I, Pepsinogen II and Gastrin 17.
The four results are entered into GastroSoft, a patented, evidence based data reduction program, to generate a patient specific report based on findings, associated risks and recommendations.

Pepsinogen I

Plasma PGI concentration is closely correlated with the mass of chief cells in the corpus mucosa. Loss of chief cells caused by mucosal corpus atrophy results in a linear decrease in blood PGI levels. PGI is an accurate marker of Gastric cancer risk - there is a 5 fold increase in risk in cases of advanced corpus atrophy.

Pepsinogen II

Pepsinogen II concentration in blood reflects the structure and function of whole stomach mucosa. An elevated plasma PGII level (>10ug/l) indicates active mucosal inflammation ("superficial Gastritis"), hallmark of Hp infection. However, because PGII is produced in the corpus and antrum, a falling ratio of PGI/PGII is an excellent marker of increasing grade of corpus atrophy.

Gastrin 17

In a normal functioning antral mucosa Gastrin 17 is the most potent form of Gastrins. Secreted by antral G-cells it reflects the structure and function of the antrum. When plasma G17 is low it can indicate antral atrophy, confirmed by a failure to respond to protein stimulation. Low or high plasma G17 values also indicate abnormalities in acid production too which is useful when considering PPI and antacid therapy.

H. pylori IgG

IgG antibodies to H. pylori provides two important pieces of information. 1) an ongoing Hp infection, or 2) a previous exposure to Hp. In GastroPanel a raised titre of antibodies to Hp helps differentiate Hp-induced atrophic gastritis from autoimmune atrophic gastritis. Although Hp IgG does not have sufficient discriminatory power to identify current active infection, it has significant advantages over other Hp tests (C13 UBT / Stool Ag) in certain conditions.

GastroPanel results are computed using GastroSoft

GastroSoft™ is a free-to-use app that is designed to assist clinicians/medical doctors in interpreting GastroPanel test results with optional anamnestic information. GastroSoft takes the individual analyte concentrations from the four GastroPanel assays and calculates the results through an evidence based and proprietary algorithm. This is useful in a clinical setting as it helps Clinical Scientists provide an interpretation of the results and translates the quantitative results from the GastroPanel assays into an easy to understand patient report.

Patient clinical information can be fed into GastroSoft and the app will adjust the diagnostic outcome and risk assessment according to patient clinical data as well as the GastroPanel assay results.

Therefore it is recommended that test request forms contain the following information:

  • H. pylori eradication status

  • Use of Proton Pump Inhibitors

  • Presence of Acid-related symptoms

  • Use of Non-steroidal anti-inflammatory drugs (NSAIDs)

The GastroPanel decision algorithm

GastroSoft reduces the data from the GastroPanel blood test to provide detailed information about the patient's stomach health. The algorithm evaluates all possible combinations of the four biomarkers along with the clinical data for each individual patient and produces a diagnosis, risk assessment and recommendation for further treatment or follow up.

GastroPanel diagnostic algorithm
PGI = Pepsinogen I; PGII = Pepsinogen II; G-17 = Gastrin 17; Hp-/+ = Helicobacter pylori Negative/Positive; PPI = Proton Pump Inhibitor; GORD = Gastroesophageal Reflux Disease
 

How does GastroPanel compare to H. pylori tests commonly used in primary care today?

GastroPanel offers significant benefits over H. pylori tests that are currently used because of the additional information provided about the disease status of the stomach mucosa. This is the single biggest advantage.

Alternative tests for H. pylori such as the C13 Urea Breath Test (UBT) and Stool antigen test (SAT) focus on determining whether the individual has an active/current H. pylori infection. This can be seen as useful, knowing when to eradicate H. pylori or confirm successful eradication are two applications that benefit from this feature. However, like all tests for H. pylori the UBT and SAT have limitations too, in particularly in terms test sensitivity under current circumstances. For example, a significant proportion of patients who present to their GP with Dyspepsia, who do not respond to dietary/lifestyle intervention, are treated with a course of PPIs in an attempt to alleviate symptoms, often before any diagnostic investigation has been performed. PPI use, Atrophic Gastritis, bleeding peptic ulcer, Mucosa-associated lymphoid tissue (MALT) lymphoma, and antibiotic use, all impede the performance of these tests. GastroPanel however, utilises a highly accurate antibody test combined with three stomach specific biomarkers to identify whether the patient has had an H. pylori infection and what the disease status of the stomach mucosa is too.

By using GastroPanel in place of H. pylori testing alone, the treating clinician can determine whether:

  1. the patient requires H. pylori eradication

  2. the patient requires antacid therapy

  3. antacids are contraindicated in the patient (e.g. achlorhydria as a result of severe corpus atrohpic gastritis)

  4. the patient should be referred for endoscopy

  5. the patient is at risk of micro-nutrient deficiency (Calcium, Iron, Magnesium, Zinc, Vitamins etc)

Comparison table - see the benefits of GastroPanel

GPanel vs Hp Tests thumb 299 x 423.jpg

Only when you compare the clinical features of GastroPanel side by side with those of H. pylori tests alone is it clear that there are distinct benefits to be gained from replacing current H. pylori tests with GastroPanel.

GastroPanel is, essentially, a test for H. pylori, but it delivers so much more - essential information that leads the patient to the correct treatment without the need for invasive investigations, and diagnoses disease status with accuracy.

Atrophic gastritis is a pre-cancerous condition that requires careful investigation by gastroscopy with biopsy analysis, and despite its prevalence (2-12%) cannot be diagnosed by the routine H. pylori tests employed today. Furthermore, diseases characterised by atrophic gastritis such as intestinal metaplasia and gastric cancer can be missed unless the patient undergoes endoscopy. With GastroPanel however, H. pylori and its sequelae can be effectively ruled out when a negative GastroPanel test result is given.

With this additional information, patients can be managed more effectively and supported through modern, clearly defined patient pathways in order to detect serious diseases of the stomach at an earlier, more treatable stage.

Table. Summary of the data provided by the GastroPanel examination compared to the C13 urea breath test or stool antigen test in the “test and treat” strategy. The reports generated by GastroSoft are based on clinical studies in which the results of GastroPanel examinations are compared with results from gastroscopy and biopsy histology examinations. This table explains the benefits of replacing H. pylori tests with the GastroPanel examination test in order to enhance such strategies.

Ready to modernise Primary Care pathways for adults with dyspepsia

GastroPanel Pathway Primary Care 03-2019

Take control of dyspepsia management and endoscopy referrals by adopting GastroPanel in your local patient pathway for dyspepsia. Simply replace H. pylori testing with GastroPanel and gain a wealth of additional information about the disease status, functionality, physiology and risks associated with the presenting symptoms.

Here is an example pathway that can be modified to your local use. If you would like more information about GastroPanel and how it can enhance your current care pathway please feel free to contact us.

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BIOHIT HealthCare Ltd

Pioneer House, Pioneer Business Park

North Road

Ellesmere Port

Cheshire CH65 1AD

United Kingdom

Tel: +44 151 550 4 550

Fax: +44 151 550 4 551

cs@biohithealthcare.co.uk

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